Samuels, Joshua et al.

Patent Trials and Appeals Board

Aug 17, 2020

2019003773 (P.T.A.B. Aug. 17, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/241,709 02/27/2014 Peter A. Lewin DREX-1138US 2529
22186 7590 08/17/2020
MENDELSOHN DUNLEAVY, P.C.
1500 JOHN F. KENNEDY BLVD., SUITE 312
PHILADELPHIA, PA 19102
EXAMINER
NGUYEN, HIEN NGOC
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
08/17/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docketing@mendelip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER A. LEWIN, YOUHAN SUNNY,
CHRISTOPHER R. BAWIEC, LEONID ZUBKOV, AN NGUYEN,
JOSHUA SAMUELS, and ELIZABETH R. PAPAZOGLOU
Appeal 2019-003773
Application 14/241,709
Technology Center 3700
Before MICHAEL J. FITZPATRICK, WILLIAM A. CAPP, and
JILL D. HILL, Administrative Patent Judges.
HILL, Administrative Patent Judge.

DECISION ON APPEAL1
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant appeals from the
Examiner’s decision to reject claims 1, 3–5, 7–9, 11, 12, 14, 15, 21–24, 27,
28, 30, and 31. Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies Drexel University as the real party in interest.
Appeal Br. 2.
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BACKGROUND
Independent claims 1 and 14 are pending. Independent claim 1,
reproduced below, illustrates the claimed invention:
1. A device that produces ultrasonic waves at a frequency of
10 kHz to 200 kHz and an acoustic intensity of 0.1
mW/cm2 to 100 mW/cm2, for therapeutic treatment
comprising:
at least one ultrasound transducer, wherein the ultrasound
transducer comprises:
a first flexible cover having a concave
configuration;
a second flexible cover having a concave
configuration opposing the first cover to form a cavity
between said first and second covers, and
a piezoelectric element attached to and positioned
between the first and second covers; and
an electronic driving module connected through an
electrical matching network and operatively associated
with at least one ultrasound transducer to supply an
excitation voltage of 20V or less to the piezoelectric
element,
wherein the first and second covers are fabricated
from a conductive material and a perimeter of the
piezoelectric element is bonded to the first and second
covers by an adhesive layer formed of a conductive
material, and
wherein the electronic driving module comprises
an oscillator.

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REFERENCES
Name Reference Date
Driller US 4,484,569 Nov. 27, 1984
Kost US 6,190,315 B1 Feb. 20, 2001
D’Sa US 6,322,532 B1 Nov. 27, 2001
Puria US 6,629,922 B1 Oct. 7, 2003
Carazo US 2007/0041595 A1 Feb. 22, 2007
Unger US 2009/0209899 A1 Aug. 20, 2009
Mulvihill US 2010/0292632 A1 Nov. 18, 2010
Castel US 2011/0040235 A1 Feb. 17, 2011
REJECTIONS2
I. Claims 1–5, 8, 9, 11–14, 22, and 24 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Mulvihill, Puria, D’Sa, Carazo, and
Unger. Final Act. 5–12.
II. Claim 15 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Mulvihill, Puria, D’Sa, Carazo, Unger, and Kost. Final
Act. 12–13.
III. Claims 21 and 23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Mulvihill, Puria, D’Sa, Carazo, Unger, and Driller. Final
Act. 13.
IV. Claim 7, 27, and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Mulvihill, Puria, D’Sa, Carazo, Unger, and Castel. Final
Act. 13–14.

2 Claims 26 and 29, rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement, were canceled.
See Appeal Br. 27 (Claims App.). Because claims 26 and 29 have been
canceled, they are no longer rejected under 35 U.S.C. § 103.
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V. Claim 30 and 31 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Mulvihill, Puria, D’Sa, Carazo, Kost, and Unger. Final
Act. 14–17.
OPINION
Rejection I: Claims 1–5, 8, 9, 11–14, 22, and 24
Claims 1, 2, 4, 8, 9, 11, 13, 14, 22, and 24
Regarding independent claims 1 and 14, the Examiner finds that
Mulvihill discloses the device as claimed, except for (1) the piezoelectric
element being “bonded to the first and second covers by an adhesive layer
formed of a conductive material,” and (2) a “driving signal of 20V or less.”
Final Act. 5–7. The Examiner finds, however, that Puria discloses using
both a conductive and a non-conductive adhesive in a transducer depending
on desired performance (Final Act. 6 (citing Puria Figs. 3A-B; 12:1–10,
12:23–32)), and concludes that it would have been obvious to modify
Mulvihill to use a conductive adhesive layer (id. at 7 (citing Puria 12:1–6
(explaining that the ability to use either conductive or non-conductive
adhesive provides “the ability to use either the adhesive . . . or conductive
end caps . . . for introducing the electrical signal to the piezoelectric
substrate.”))).
The Examiner further finds that the claimed excitation voltage of
“20V and less is a designer choice that only require[s] ordinary skill in the
art.” Id. The Examiner relies on D’Sa and Carazo to teach using an
excitation voltage of 20V or less. Id. (citing D’Sa 3:60–67 (“The voltage
(rms) of the applied signal is generally from about 30V to 300V, although
lower voltages are preferred.”)); see also Carazo ¶¶ 31, 92, 112 (Table 5)
(showing performance of a transducer with an input of 2V, 10V, and 20V)).
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The Examiner relies on Unger to establish that 20V is a known excitation
voltage for ultrasound for drug delivery. Id. (citing Unger ¶ 81 (“An
ultrasonic signal (typically of 40 kHz) is generated . . . by way of the signal
generator . . . providing a peak-to-peak voltage of 20 V to the ultrasonic
transducer 104. This provides an acoustic flux of approximately 200
mW/cm2.”).
Appellant argues claims 1, 2, 4, 8, 9, 11, 13, 14, 22, and 24 as a group.
We select claim 1 as representative. Claims 2, 4, 8, 9, 11, 13, 14, 22, and 24
stand or fall with claim 1.
Appellant argues that, although Mulvihill discloses the output
frequency and acoustic intensity recited in the preamble of independent
claim 1 and the body of independent claim 14, it requires 200V to produce
such output, which is ten times the “20V or less” recited in claims 1 and 14.
Appeal Br. 11, 12 (citing Mulvihill ¶ 69). Indeed, Appellant argues, “none
of the cited references discloses a device that produces [the claimed output]
using an excitation voltage of 20 V or less.” Id. at 12. Appellant notes that
Unger uses an excitation voltage of 20V and outputs an acoustic intensity of
200mW/cm2, or double the acoustic intensity recited in the claims (id. (citing
Unger ¶ 81)), and Carazo uses an excitation voltage of 2–20V and “operates
at 0.1–8 kHz which is [less than the] claimed range of 10-200 kHz” (id.
(citing Carazo Tables 4–6)). Regarding D’Sa, Appellant notes that it only
discloses an excitation voltage “from about 30V to 300V, although lower
voltages are preferred where a suitably responsive piezoelectric material is
used.” Id.
Similarly, Appellant argues that the Examiner erred in concluding that
a skilled artisan would have modified Mulvihill to use the input voltages of
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D’Sa, Carazo, and Unger. Appeal Br. 13. According to Appellant, the
Examiner (1) incorrectly treats the excitation voltage, frequency, and
acoustic intensity of “ultrasonic transducers independently when, in fact,
they are interrelated,” and (2) fails to consider “very significant structural
differences [among] the prior art ultrasonic transducers and the effect that
these structural differences will have on the excitation voltage, frequency,
acoustic intensity, and displacement of the ultrasonic transducers.” Id.
Regarding combinability of Mulvihill and D’Sa specifically,
Appellant contends that a skilled artisan would consider the structural
differences among the prior art transducers, and the interrelationship of the
inputs and outputs, when considering modifying Mulvihill, and “would not
have a reasonable expectation of successfully generating ultrasonic waves
having the claimed frequency and acoustic intensity by modifying the
transducer of Mulvihill based on the teachings of D’Sa.” Id. at 14–16 (citing
Lewin Declaration3 for the proposition that different transducers required
different excitation voltages).
Regarding combinability of Mulvihill and Carazo specifically,
Appellant argues that a skilled artisan would not have used Carazo’s 20V
input with Mulvihill’s transducers, because the structure and intended use of
the transducer of Mulvihill’s micro-patch are different from the structure and
intended use of the transducer of Carazo’s hearing aid, and “the media that
transmit the generated ultrasound waves” differ –– bone conduction for
Carazo and soft tissue conduction for Mulvihill.” Appeal Br. 16. According
to Appellant, Carazo’s excitation voltage is disclosed solely for its “thunder

3 Declaration under 37 C.F.R. § 1.132 of inventor Peter Lewin, filed
December 12, 2018.
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actuator 12 that is shown and described in Fig. 7b of Carazo,” and one
skilled in the art would understand that different transducers “may require
different excitation voltages.” Id. at 17 (citing Carazo ¶¶ 106–107).
Regarding combinability of Mulvihill and Unger specifically,
Appellant argues that Unger discloses, inter alia, using a 20V excitation
voltage generating an ultrasonic signal having an acoustic intensity of
approximately 200 mW/cm2 (double the upper limit of the acoustic intensity
of claim 1), which “clearly supports the conclusions of Dr. Lewin that
structural differences in transducers [generate] different acoustic intensities
even when using the same excitation voltage of 20 V.” Appeal Br. 18
(citing Unger Fig. 3).
While we have considered these arguments regarding the
combinability of Mulvihill with each of D’Sa, Carazo, and Unger, we find
the arguments unavailing at least because they consider the combinability of
Mulvihill with each of the secondary references separately, rather than
considering the combined teachings of the combined references as a whole,
and how those teachings come together with the knowledge of a skilled
artisan at the time of the invention to render the claimed invention obvious.
Additional analysis of the Examiner’s reasoning is set forth below.
The Examiner responds that Appellant’s arguments are not directed to
device structure, and that
• Mulvihill discloses a transdermal micro-patch intended
to transmit ultrasonic waves into soft tissue to aid transport of
fluid into the tissue;
• D’Sa, also dealing with transdermal applications,
supplements Mulvihill’s teachings by suggesting that an
ordinary artisan would be motivated to use low excitation
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voltages, preferred for obvious reasons, where a suitably
responsive piezoelectric material is used [col.3, 11.60-67];
• Carazo teaches that excitation voltages of 20V or lower
can be used with piezoelectric ceramic materials that are not
excluded by Appellant’s disclosure
Ans. 14–15.
Further, the Examiner contends, D’Sa “discloses explicitly that the
excitation voltage depends on the material used.” Id. at 15. According to
the Examiner, using “better energy saving material” could lower the
excitation voltage required to output the claimed frequency of 10 kHz to 200
kHz and an acoustic intensity of 0.1 mW/cm2 to 100 mW/cm2 to 20V, and
Carazo discloses that such an “energy saving material” exists. Id.
Regarding Appellant’s argument that Mulvihill’s transdermal micro-
patch has different structure and intended use than Carazo’s hearing aid, the
Examiner counters that such an intended use argument “is not persuasive
because the device claim does not have any particular structural limitations
. . . exclusive to either a hearing aid or transdermal patch,” and an
“ultrasound transducer is [used] to transmit ultrasound [for] a myriad of
applications,” including medical uses as disclosed in both Mulvihill and
Carazo. Ans. 15.
Appellant replies that, because the claims recite an ultrasound
frequency of 0.1–8 kHz, the claim includes limitations that are exclusive to a
transdermal patch. See Reply Br. 5.
Appellant’s argument, that the claimed frequency limits the intended
use of the device to transdermal patches, lacks evidentiary support. Further,
intended use is a functional limitation that does not differentiate an apparatus
claim from the prior art. See Hewlett-Packard Co. v. Bausch & Lomb Inc.,
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909 F.2d 1464, 1469 (Fed. Cir. 1990) (“apparatus claims cover what a
device is, not what a device does”). Still further, Appellant has not provided
evidence of the relevant structural difference between Mulvihill’s
transdermal micro-patch and Carazo’s hearing aid. Also, as explained
above, in the argument, Appellant’s argument regards only the disclosure of
Mulvihill and Carazo, rather than the combined teaching of the applied
references and the knowledge of a skilled artisan.
To counter Dr. Lewin’s opinion that the driving signal of D’Sa is not
directly applicable to Mulvihill’s transducer because structural differences in
the transducers significantly affect transducer displacement, the Examiner
contends that Appellant’s own disclosure indicates that figuring out the
dimensions and other characteristics of a transducer for a given input and
output is within the knowledge of a skilled artisan for a given piezoelectric
ceramic material. Ans. 16 (citing Spec. ¶ 29 (“[P]iezoelectric element 14
preferably has a thickness, an overall dimension and a piezoelectric
coefficient sufficient to enable production of low intensity and low pressure
amplitude ultrasound waves from a minimal amount of excitation voltage,”
and “can be constructed from any suitable piezoelectric material, including
piezoelectric ceramics, such as lead zirconate titanate and hard lead
zirconate titanate.”)). The Examiner further contends that, for cymbal
transducers, “[i]t is the material that dictates the driving voltage as pointed
out by D’Sa.” Id. at 17 (citing D’Sa 3:60–67 (“lower voltages are preferred
where a suitably responsive piezoelectric material is used”)). The Examiner
continues that:
The working principle of the cymbal transducer is to simply use
voltage to oscillate the end caps (see appellant’s Fig. 4a, stage 0
and stage 1; element 26). With a more flexible material, less
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voltage is required to oscillate the end caps. Mulvihill's device
and appellant’s device have the same structure using the same
treatment intensity and frequency, but have a different driving
voltage. The only reasonable explanation is that they use a
different material as evidenced by D’Sa.
Id. Then, the Examiner continues, “Carazo’s teach[es] using piezoelectric
ceramic materials to allow use of more energy efficient 20V or less.” Id.
Appellant replies that the Examiner’s reasoning is incorrect,
unsupported by evidence, and contradicted by Appellant’s Specification and
the Lewin Declaration. Reply Br. 2. According to Appellant, the
Specification of the present invention discloses, instead, that transducer
energy efficiency and transducer output depend not just on the material, but
on “the material, geometry and dimensions of piezoelectric element 14, the
material, structure (material, shape, cavity depth, outer diameter and apex
diameter) and acoustic impedance of covers 16, 18, the volume and shape of
cavity 20, how transducers 12 are mounted to housing 50[,] and the
electrical matching network.” Id. (quoting Spec. ¶ 37). Thus, Appellant
argues, the Examiner’s contention “that a more energy efficient piezoelectric
material could lower the driving voltage of the D’Sa device to 20V or less
. . . is pure speculation . . . and inconsistent with the teachings of D’Sa and
the facts and evidence presented in [Appellant’s Specification] and the
Lewin Declaration.” Id. at 3–5. Appellant further argues that Carazo does
not explicitly disclose a material that would lower the driving voltage of
D’Sa to 20V or less. Id.
Appellant also argues that using paragraph 29 of the instant
Specification to support the Examiner’s conclusion of obviousness indicates
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that the Examiner employed impermissible hindsight in the rejection. See
Reply Br. 6–7.
While using Appellant’s own disclosure to provide a reason for
combining the prior art can be indicative of impermissible hindsight use,
here, the Examiner cites Appellant’s Specification as evidence that a skilled
artisan would understand how to combine the thickness, overall dimension,
and piezoelectric coefficient (indicative of material selected) to “enable
production of low intensity and low pressure amplitude ultrasound waves
from a minimal amount of excitation voltage.” Ans. 16. We discern no
error on the Examiner’s reliance on Appellant’s Specification as evidence of
the knowledge of a skilled artisan at the time Appellant’s invention. Indeed,
Appellant left any and all working combinations of these characteristics to
the knowledge of a skilled artisan. See Spec. ¶ 37 (“[E]nergy efficiency of
transducer 12 is dependent in part upon the material, geometry and
dimensions of piezoelectric element 14, the material, structure and acoustic
impedance of covers 16, 18, the volume and shape of cavity 20, how
transducers 12 are mounted to housing 50 and the electrical matching
network. Additionally, the generated ultrasound intensity, pressure
amplitude and frequency is dependent upon the material, thickness and
diameter of piezoelectric element 14, and the material, shape, cavity depth,
outer diameter and apex diameter of first and second covers 16, 18.”). To
now say the exact combination(s) required to obtain the claimed transducer
output from the claimed transducer input is beyond the knowledge of a
skilled artisan is disingenuous.
Further, the prior art relied on by the Examiner makes clear that it is
both material and geometry that are relevant to transducer efficiency and
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performance. Indeed, Mulvihill discusses transducer geometry and material
selection generally, and incorporates a disclosure of specific cymbal-shaped
flextensional transducers by reference. See Mulvihill ¶¶ 18–20 and 41
(incorporating by reference US 5,729,077 entitled Metal-Electroactive
Ceramic Composite Transducer and US 6,665,917 entitled Method of
Fabricating a Planar Pre-stressed Bimorph Actuator).
Puria also discloses a cymbal-type flextensional transducer, and
discusses the differing geometries and materials for its transducers. Id.
at 4:40–50 (“metal-shell or plastic-shell, end caps” and “[t]he shape of the
shell to a large extent determines the mechanical advantage”), 6:6–13 (“he
actuator may be round or of a prismatoid shape,” “[t]he end caps . . . may be
made of a superelastic alloy, a metal alloy, or a polymeric material,” and the
size of the . . . actuator is less than 5 mm but . . . is not limited to this
dimension”), 8:44–67 (the substrate is “selected from piezoelectric cermaics
such as PZT, PLZT, PMN, PMN-PT” and “the substrate itself may be a
single layer or . . . a multi-layer composite,” “[t]he substrate typically is
generally circular, although the substrate is not limited such a
configuration”), 9:1–5 (“configuration of the end caps, to a large extent,
determines the displacement amplification”), 9:24–30 (“the invention does
not exclude the use of ceramic, polymer, or other types of piezo elements”
and can include “several types of piezo-metal or piezo-plastic composite
actuators”), and 10:61–65 (“[the] angle of the side panels . . . may be altered
to, e.g., variously maximize the size of the planar diaphragm . . or enhance
the mechanic advantage of the planar diaphragm”). Puria, thus, informs us
that the geometry and material of transducers has an impact on their
performance that would be known and appreciated by a skilled artisan.
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Given this disclosure in Puria, we agree with the Examiner that, although
“none of the cited references discloses a device that produces [the claimed
output] using an excitation voltage of 20 V or less,” a skilled artisan would
understand how to select and refine the material and geometry of a
transducer to provide an output appropriate for its intended use with a
desired excitation voltage. Appeal Br. 12.
D’Sa discloses transducers that transmit ultrasonic waves into soft
tissue, and is directed to a more efficient transducer. See, e.g., D’Sa 2:41–
47. D’Sa discloses preferred piezoelectric materials, such as a piezoceramic
discussed in Mulvihill, and discloses that the excitation voltage can be 30V –
300V “although lower voltages are preferred where a suitably responsive
piezoelectric material is used.” Id. at 3:36–37, 3:60–67. While Puria
informs us that it was known to select and refine the material and geometry
of a transducer to provide an output appropriate for the transducer’s intended
use for a given excitation voltage, D’Sa informs us that lower excitation
voltages are preferred and depend on the piezoelectric material used.
Carazo also discloses a piezoelectric flextensional transducer that
outputs a range of 10 kHz – 200 Khz. Carazo, Abstract, ¶ 30–31. The
transducer can be a cymbal type having, e.g., a piezoelectric ceramic with a
metal shell. Carazo, ¶ 88, 92. Carazo supplies an excitation voltage of less
than 20V to transducers having varied housing materials, although the data
collected and disclosed is not specifically for a cymbal-type transducer as
used in Mulvihill. Id. ¶ 112 (Table 5). Thus: (1) Puria informs us that it
was known to combine the material and geometry of a transducer to provide
an output appropriate for its intended use with a given excitation voltage; (2)
D’Sa informs us that lower excitation voltages are preferred and depend on
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the piezoelectric material used; and (3) Carazo informs us that a 20V
excitation voltage can be used with a piezoelectric ceramic, which is not
excluded from the materials of Appellant’s invention. Appellant has not
informed us specifically why the data of Carazo’s Table 5, cited by the
Examiner, would not be understood to a skilled artisan to apply to a cymbal-
type transducer.
Further, the Examiner’s findings and conclusions underlying the
determination that a skilled artisan would understand how to design the
material and geometry of a transducer to have the desired input and output is
based on the Examiner’s understanding that the excitation voltage and the
frequency and intensity of a transducer are interrelated, and we therefore are
not persuaded by Appellant’s argument that the Examiner incorrectly treats
the excitation voltage and the frequency and acoustic intensity of “ultrasonic
transducers independently when, in fact, they are interrelated,” or the
Appellant’s argument that the Examiner fails to consider “very significant
structural differences [among] the prior art ultrasonic transducers and the
effect that these structural differences will have on the excitation voltage,
frequency, acoustic intensity and displacement of the ultrasonic
transducers.” Appeal Br. 13. It is exactly this understanding and
consideration that leads to the Examiner’s (and to our) determination of
obviousness in this case.
Although Appellant’s intended use argument might otherwise imply
an argument that the teachings of Puria and Carazo are not applicable to
Mulvihill’s transducer because the prior art references are non-analogous art,
Appellant does not refute the Examiner’s determination that the field of
endeavor of the prior art references is ultrasound transmission for medical
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uses.4 Final Act. 18; see also Ans. 15. We discern no error in the
Examiner’s determination. All of the devices are directed to ultrasound
transmission into the human body and, even if the frequency and acoustic
intensity desired for hearing aids may differ from the frequency and acoustic
intensity desired for ultrasound into other body tissue, the Examiner’s
determines that the ability to design a cymbal transducer to achieve a given
input and output within the level of ordinary skill in the art, and Appellant
has not provided factually-supported reasoning that persuades us that a
skilled artisan would not consider teachings for a hearing aid relevant to
transducers for other body tissue.
In the Reply Brief, Appellant argues for the first time that “Mulvihill
does not include an electrical matching network as required by all of the
claims of the present application.” Reply Br. 8. This argument was not
raised in the Appeal Brief, is not responsive to any argument raised in the
Examiner’s Answer, and good cause has not been shown. See 37 C.F.R. §
41.41(b)(2). We will not consider this argument because it was not timely
raised, and we have not received the Examiner’s position on the proper
construction of this term and whether the prior art reads on such
construction.
For the reasons explained above, we sustain the rejection of claim 1.
Claims 2, 4, 8, 9, 11, 13, 14, 22, and 24 fall with claim 1.

4 Although the Examiner does not use the term “field of endeavor,” because
an explicit challenge of the references as non-analogous was not set forth,
we understand the Examiner to have made such a finding.
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Claim 3
Dependent claim 3 recites “a conductive epoxy” bonding “the first
and second covers to the piezoelectric element,” and each of the first and
second covers comprising an apex having “a circular configuration.” The
Examiner finds that Mulvihill discloses conductive epoxy adhesive. Final
Act. 6, 12 (citing Mulvihill ¶¶ 26, 38, 58, 65–66, Figs. 2–4, 6). The
Examiner finds that both Mulvihill and Puria disclose an apex with a circular
configuration. Final Act. 10 (citing Mulvihill ¶¶ 29–31, Figs 1, 3d (“element
2”); and Puria Figs.1, 2B, 2C, 4E (“cap 160–162 is [a circular] apex” and
“flextensional transducer 132 has circular apex”)). The Examiner asserts
that apex shape is a design choice, which we consider to be the stated
motivation for using Puria’s circular apex in Mulvihill’s transducer. Id.
Appellant argues that the Examiner erred in finding that (1)
Mulvihill’s adhesive is a conductive epoxy, and (2) Mulvihill’s transducer
apex is circular. Appeal Br. 20. Appellant also argues that the Examiner has
not established that one skilled in the art would replace Mulvihill’s
transducer apex with Puria’s circular end caps 160, 162 “with an expectation
of successfully arriving at the present invention including being able to meet
the claimed frequency, acoustic intensity and excitation voltage limitations,”
and “in view of the structural differences between the devices of Mulvihill
and Puria and the conclusions of Dr. Lewin regarding the importance of such
structural differences.” Id.
Regarding the claimed conductive epoxy adhesive, the Examiner
responds that Puria discloses using conductive epoxy adhesive, and
Mulvihill explicitly discloses using adhesive to secure portions of its device.
See Ans. 19 (citing Puria Fig. 3A, 12:1–10; Mulvihill ¶ 38). Appellant
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replies that Puria never uses the term epoxy as claimed, instead only
disclosing a conductive adhesive. Reply Br. 10.
Regarding conductive epoxy, Puria discloses a cymbal transducer
with the substrate adhered to the end caps using either a conductive or non-
conductive adhesive. See Puria 9:55–59, Fig. 1A. One example of an
adhesive used in Puria is “MASTER BOND” (id. at 9:55–59), which we
understand to be an epoxy adhesive. Thus, Puria disclose an epoxy
adhesive. Puria discloses that selection among conductive or non-
conductive adhesives “places the ability to use either the adhesive . . . or
conductive end caps . . . as the site for introducing the electrical signal to the
piezoelectric substrate.” Id. at 12:28–31. For this reason, we are not
persuasive that the prior art lacks disclosure of a conductive epoxy adhesive.
Regarding the circular apex, the Examiner responds that the rejection
does not suggest replacing Mulvihill’s transducers 2 with Puria’s end caps
160, 162, because the Examiner finds that both Mulvihill and Puria disclose
circular apexes –– though it is clearer to see that Puria’s device has a circular
apex. Ans. 18.
Appellant replies that it is the Examiner’s initial burden to establish
that Mulvihill’s transducer has a circular apex, and the Examiner has failed
to establish that Mulvihill’s apex is circular, which is the case because
Mulvihill’s transducer apex is neither shown nor described. Reply Br. 9.
We agree with Appellant’s contention on this point. Puria, however,
discloses a circular apex.
Regarding modifying Mulvihill to include Puria’s circular apex,
Appellant argues that the Lewin’s Declaration “demonstrates that structural
differences will influence the frequency, acoustic intensity and excitation
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voltage of the device,” and Appellant’s Specification “clearly indicates that
[apex shape] influence[s] the frequency, acoustic intensity and excitation
voltage of the device.” Id. at 10.
However, a circular apex was known from the disclosure of Puria.
Further, it is Puria that, as explained above, informs us that it was known to
select and refine the material and geometry of a transducer to provide an
output appropriate for the transducer’s intended use with a given excitation
voltage. Thus, we agree with the Examiner’s determination that a skilled
artisan could apply Puria’s circular apex teaching to Mulvihill, particularly
given Puria’s suggestion of using a circular apex, and in an effort to design a
transducer having a desirable input/output performance.
For these reasons, we sustain the rejection of claim 3.
Claim 5
Dependent claim 5 recites that the “distance between the piezoelectric
element and the apex of the first cover is 0.01 mm to 5 mm.” We
understand this claimed distance to be shown in Appellant’s Figure 4(c).
The Examiner does not find this teaching in the prior art of record, asserting
instead that Mulvihill’s device “is a small device similar to a bandage
therefore it would have been obvious to one of ordinary skill in the art at the
time of the invention that a distance between the piezoelectric element and
the apex of the first cover is 0.01 mm to 5 mm,” which would be “a design
choice that does not offer operational advantage” or novelty. Final Act. 10.
Appellant argues that the Examiner’s assertion is incorrect, because
the claimed distance “defines one dimension of the cavity which generates
the ultrasonic output of the device,” and “changes to this distance would be
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expected to influence the operating parameters of this device since this will
alter the structure of the device.” See Appeal Br. 20–21.
The Examiner responds that Appellant’s claimed distance is obvious
because “distance influences the operating parameters of the device [by
altering] the structure of the device.” Ans. 18.
Appellant replies that the Examiner’s positions contradict themselves,
because the Examiner first says that the claimed distance is “a design choice
that does not offer operational advantage,” and then says that the claimed
distance influences the operating parameters of the transducer. Reply
Br. 11.
The Examiner considers the claimed distance to be a design choice.
Final Act. 10. Even if the claimed distance (an aspect of the transducer’s
geometry) influences the operating parameters of the transducer, Appellant
has not alleged or explained why such influence of transducer operating
parameters defines a “novel or unexpected result.” See In re Woodruff, 919
F.2d 1575, 1578 (Fed. Cir. 1990) (where the difference between the claimed
invention and the prior art is some range within the claims, “the applicant
must show that the particular range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior art range”).
Indeed, Appellant’s Specification identifies no such unexpected results and,
as explained above, Puria informs us that it was generally known to select
and refine the material and geometry of a transducer to influence operating
parameters of the transducer, implying that the result of the claimed distance
would have been expected. We find no evidence in Appellant’s disclosure
of unexpected results attributed to the claimed distance.
Claim 12
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Dependent claim 12 recites the device being “a flexible patch or
bandage that can be worn by a patient” and weighing “200 grams or less.”
The Examiner finds that Mulvihill’s device “is a flexible patch or bandage
that can be worn by a patient.” Final Act. 11 (citing, e.g., Mulvihill,
Abstract (“transdermal micro-patch”), ¶ 23 (“The invention can be integrally
manufactured, including lightweight and compact power electronics and
control mechanisms, so as to have a small footprint to minimize the tissue
area affected by the device and to minimize discomfort to the wearer, thus
providing a compact, wearable solution.”)). The Examiner asserts that,
although Mulvihill does not disclose its device weighing 200 grams or less,
Mulvihill’s patch “is a micro patch therefore it would have been obvious to
one of ordinary skill in the art at the time of the invention that it is very light
and [weigh] 200 grams or less.” Id.
Appellant argues that Mulvihill fails to disclose a device
weighing 200 grams or less, and “it is pure speculation that a working device
could be built based on the teachings of Mulvihill which weighs 200 grams
or less.” Appeal Br. 21. Appellant further argues that, although Mulvihill
discloses a micro-patch, Mulvihill’s device “includes a reservoir 3, a pump 4
and a circuit 5, [] flextensional transducers and wiring for these transducers,”
which “would be expected to contribute to the weight of the Mulvihill
device” and are not accounted for by the Examiner’s assertion. Id.
The Examiner responds that, based on this logic, Appellant’s device
would weigh more than 200 grams, because Appellant’s device also includes
“a reservoir, a pump, a circuit, a plurality of flextensional transducers and
wiring for these transducers.” Ans. 20. According to the Examiner, if
Appellant’s device can include all of the components and weigh 200 grams
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or less, “then it would be reasonable to assume” Mulvihill’s patch also
weighs 200 grams or less, and it would have been obvious that Mulvihill’s
micro-patch “should be very light weight — similar to a bandage.” Id.
Appellant replies that “claim 12 does require a driving module
[recited in claim 1] and thus these six elements which are all part of the
driving module of Mulvihill need to be counted in the device weight for the
Mulvihill device.” Reply Br. 11–12. Appellant contends that the claimed
device is “so much lighter than Mulvihill” because its driving voltage is
lower and “thus can be generated using a lightweight power source.” Id.
at 12. According to Appellant, “[o]ne reason that the driving voltage of the
device of claim 12 is so low is the inclusion of a matching network, which is
not part of the Mulvihill device.” Id.
Again, Appellant’s argument regarding the import of the electrical
matching network in rendering the claims patentable over the prior art was
not raised in the Appeal Brief, is not responsive to an argument raised in the
Examiner’s Answer, and good cause has not been shown for delayed
presentation of the argument. See 37 C.F.R. § 41.41(b)(2). Therefore, we
will not consider this argument because it was not timely raised, and we
have not received the Examiner’s position on the proper construction of this
term, whether the prior art reads on such construction, its influence on
device weight. Such influence is not set forth in Appellant’s Specification.
See Spec. ¶¶ 37–38, and 44.
We note, however, that Mulvihill recognizes device weight as a result
effective variable in stating that the invention can include “lightweight and
compact power electronics and control mechanisms, so as to have a small
footprint to minimize the tissue area affected by the device and to minimize
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discomfort to the wearer, thus providing a compact, wearable solution.”
Mulvihill ¶ 23. Here, the mere carrying forward of Mulvihill’s concept of a
lightweight, wearable device performing the same function by substantially
the same process “is not such an invention as will sustain a patent.” See In
re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law
that a mere carrying forward of an original patented conception involving
only change of form, proportions, or degree, or the substitution of
equivalents doing the same thing as the original invention, by substantially
the same means, is not such an invention as will sustain a patent, even
though the changes of the kind may produce better results than prior
inventions.”). For this reason, we sustain the rejection of dependent
claim 12.
Rejections II–V: Claims 7, 15, 21, 23, and 27, 28, 30, and 31
Appellant makes no argument that claims 7, 15, 21, 23, and 28 are
patentable if claims 1 and 14, from which they depend, are not patentable
over Mulvihill, Puria, D’Sa, Carazo, and Unger. Thus, for the reasons
explained above regarding Rejection 1, we sustain the rejection of claims 7,
15, 21, 23, and 28.
Claims 27, 30, and 31
Dependent claim 27 recites a method of wound treatment using the
device of claim 1, “wherein the device is positioned against an epidermal
tissue of the patient proximate to a site of the wound to achieve a therapeutic
effect.” Claims 30 and 31 depend from claim 27.
Appellant argues that none of the prior art relied on by the Examiner
discloses wound treatment. Appeal Br. 22. According to Appellant,
Mulvihill and Castel disclose “transdermal administration of fluids,” D’Sa
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discloses “a sonophoresis device,” Carazo discloses “a hearing aid,” and
Unger discloses “a storage device and has no therapeutic purpose.” Id.
The Examiner responds that Mulvihill discloses ultrasound wound
treatment. Ans. 20 (citing Mulvihill Abstract, ¶¶ 4, 6, 23) (“deliver[ing a]
drug by ultrasound into the wound is wound treatment by ultrasound
mediated therapy”). The Examiner further responds that “any ultrasound
device capable of generating the claimed operating ranges would affect
treatment.” Id.
Appellant replies that the Examiner does not appreciate that the
claimed ultrasound mediated therapy requires that ultrasound “bring about
the wound therapy.” Reply Br. 12. Appellant contends Mulvihill’s wound
treatment is instead brought about by its drug, not ultrasound. According to
Appellant, while it is true that an ultrasound device capable of generating the
claimed operating range would affect wound treatment, the prior art does not
disclose affecting wound treatment with ultrasound, only the present
invention appreciates ultrasound as a wound treatment therapy, and therefore
a conclusion that such use is obvious must be “based on impermissible
hindsight.” Id. at 12–13.
We decline to require that in vivo testing substantiate the Examiner’s
finding that Mulvihill discloses wound treatment. Further, this “bringing
about” argument was not raised in the Appeal Brief, is not responsive to an
argument raised in the Examiner’s Answer, and good cause has not been
shown. See 37 C.F.R. § 41.41(b)(2). Therefore, we will not consider this
argument because it was not timely raised, and we have not received the
Examiner’s position on the proper construction of this limitation and
whether Mulvihill reads on such construction. It seems unlikely that the
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language of claim 27 requires that Mulvihill explicitly disclose that the
ultrasound aspect of its treatment is what “brings about” wound healing.
For this reason, we sustain the rejection of claims 27, 30, and 31.
DECISION
The Examiner’s rejections are affirmed as to all of the pending claims.
CONCLUSION
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis  Affirmed Reversed
1–5, 8, 9,
11–14,
22, 24
103(a) Mulvihill, Puria,
D’Sa, Carazo, Unger
1–5, 8, 9,
11–14, 22,
24

15 103(a) Mulvihill, Puria,
D’Sa, Carazo, Unger,
Kost
15
21, 23 103(a) Mulvihill, Puria,
D’Sa, Carazo, Unger,
Driller
21, 23
7, 27, 28 103(a) Mulvihill, Puria,
D’Sa, Carazo, Unger,
Castel
7, 27, 28
30, 31 103(a) Mulvihill, Puria,
D’Sa, Carazo, Kost,
Unger
30, 31
Overall
Outcome
  1, 3–5, 7–9,
11, 12, 14,
15, 21–24,
27, 28, 30,
31

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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED